Dolor irruptivo en cáncer: Ensayo aleatorizado comparativo entre citrato de fentanilo oral transmucosa (CFOT) y sulfato de morfina de liberación inmediata (MSIR®)

Translated title of the contribution: Irruptive pain in cancer: A randomized comparative trial of oral transmucosal fentanyl citrate (OTFC) versus immediate-release morphine sulphate (MSIR®)

Paul H. Coluzzi, Lee Schwartzberg, J. D. Conroy, S. Charapata, M. Gay, M. A. Busch, J. Chavez, J. Ashley, D. Lebo, M. McCracken, R. K. Portenoy

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Oral transmucosal fentanyl citrate (OTFC: Actiq®) is a drug formulation used for the management of irruptive pain crisis in patients with cancer. Previous comparative and open studies have shown that OTFC is more effective than the opiates commonly used in these patients for the management of irruptive pain crisis. The aim of this study was to compare OTFC versus immediate-release morphine sulphate (MSIR®) for the management of irruptive pain in patients treated with a fixed opiate therapy. This cross-sectional, multiple, randomized, double-blind and double dummy study was conducted in 19 community or university hospitals and clinics in United States and 134 oupatient adults with cancer participated in it. Patients were being treated with a fixed opiate therapy, equivalent to 60-1.000 mg.day-1 of oral morphine or 50-300 mg.h-1 of transdermal fentanyl, using an "effective" dose of MSIR® (15-60 mg) as defined by the inclusion criteria, and suffered 1 to 4 irruptive pain crisis daily. In a first open period of treatment, the OTFC dose was titrated so that a single transmucosal unit (200-1.600 mg) would provide enough pain relief with acceptable side effects. Patients in which this titration could be successfully performed were included in the double-blind study phase and received ten pre-numbered packs of capsules and transmucosal oral units randomly distributed. Five of these packs included the effective OTFC dose and placebo capsules; the other five packs included OTFC placebo and capsules with the effective dose of MSIR®. Patients used one pack of study medication for each irruptive pain crisis to be managed. Pain severity (PS) was recorded, as well as pain relief (PR) and global effectiveness (GE) of the medication. Differences in the severity of pain (DSP) were calculated and DSP at 15 minutes was used as the main effectiveness criteria. Adverse events were also recorded. An effective dose of OTFC could be titrated in 69% of patients (93/134). The results obtained with OTFC (PS, DSP and PR) at all assessed points were significantly better than those obtained with MSIR®. GE was also better with OTFC and more patients preferred to continue with OTFC instead of MSIR® after the study. Somnolence, nausea, constipation and dizziness were the most common side effects associated to the medication. In conclusion, OTFC was more effective than MSIR® for the management of irruptive pain crisis in patients with cancer.

Original languageSpanish
Pages (from-to)306-316
Number of pages11
JournalRevista de la Sociedad Espanola del Dolor
Volume9
Issue number5
StatePublished - Jun 1 2002

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Fentanyl
Morphine
Pain
Opiate Alkaloids
Pain Management
Capsules
Double-Blind Method
Cancer Pain
Placebos
Neoplasms
Drug Compounding
Community Hospital
Dizziness
Constipation
Nausea
Therapeutics

All Science Journal Classification (ASJC) codes

  • Anesthesiology and Pain Medicine

Cite this

Dolor irruptivo en cáncer : Ensayo aleatorizado comparativo entre citrato de fentanilo oral transmucosa (CFOT) y sulfato de morfina de liberación inmediata (MSIR®). / Coluzzi, Paul H.; Schwartzberg, Lee; Conroy, J. D.; Charapata, S.; Gay, M.; Busch, M. A.; Chavez, J.; Ashley, J.; Lebo, D.; McCracken, M.; Portenoy, R. K.

In: Revista de la Sociedad Espanola del Dolor, Vol. 9, No. 5, 01.06.2002, p. 306-316.

Research output: Contribution to journalArticle

Coluzzi, PH, Schwartzberg, L, Conroy, JD, Charapata, S, Gay, M, Busch, MA, Chavez, J, Ashley, J, Lebo, D, McCracken, M & Portenoy, RK 2002, 'Dolor irruptivo en cáncer: Ensayo aleatorizado comparativo entre citrato de fentanilo oral transmucosa (CFOT) y sulfato de morfina de liberación inmediata (MSIR®)', Revista de la Sociedad Espanola del Dolor, vol. 9, no. 5, pp. 306-316.
Coluzzi, Paul H. ; Schwartzberg, Lee ; Conroy, J. D. ; Charapata, S. ; Gay, M. ; Busch, M. A. ; Chavez, J. ; Ashley, J. ; Lebo, D. ; McCracken, M. ; Portenoy, R. K. / Dolor irruptivo en cáncer : Ensayo aleatorizado comparativo entre citrato de fentanilo oral transmucosa (CFOT) y sulfato de morfina de liberación inmediata (MSIR®). In: Revista de la Sociedad Espanola del Dolor. 2002 ; Vol. 9, No. 5. pp. 306-316.
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T2 - Ensayo aleatorizado comparativo entre citrato de fentanilo oral transmucosa (CFOT) y sulfato de morfina de liberación inmediata (MSIR®)

AU - Coluzzi, Paul H.

AU - Schwartzberg, Lee

AU - Conroy, J. D.

AU - Charapata, S.

AU - Gay, M.

AU - Busch, M. A.

AU - Chavez, J.

AU - Ashley, J.

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